CQV Process Engineer
Description
CQV Process Engineer Level II - III
Description:
Azzur Group is looking for CQV Process Engineers in the surrounding Philadelphia area for New Facility consulting projects. Current project locations include Central Jersey, Philadelphia, and the Lehigh Valley area. This is a great opportunity to expedite your career growth through exposure to projects across multiple client sites and functions! If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!
What you will achieve:
· Gain exposure and apply your expertise to the commissioning, qualification, and validation of key bench top and some process equipment ensuring top quality standards are being met.
· Leverage and develop your problems solving abilities as you support the assessment of deviations, investigation, and change controls for validation activities in a regulatory setting.
· Apply and expand your knowledge of cGxP regulations as you author and execute validation studies related to the initial startup of cGMP operations and/or change controls.
· Provide top quality service to our valued customers and end users by ensuring all needs are met and that work performed is of the highest quality standards.
· Grow your career through faced paced assignments with multiple clients as you continue your career with Azzur!
Requirements
Ideal Qualifications:
· 5 - 10 years of Commissioning, Qualification and Validation (CQV) experience in a regulated environment is required.
· New Facility Start-Up experience.
· Experience in Temperature Mapping: Stand-Alone chambers, Warehouse Walk-In Cold Rooms / Freezers.
· Experience in Packaging Lines and associated equipment
· Experience in Downstream / Upstream processes.
· A proven track record of quality work in a GxP environment with excellent attention to details. Technical writing experience is required. Must be able to write IOQ / PQs, SOPs, URSs, RAs, Summary Reports.
· At least 5 years’ of industry experience with the successful validation, qualification, or requalification of laboratory and / or manufacturing equipment in a cGxP regulated environment. Examples of equipment are; incubators, plate readers, refrigerators / freezers, mixers, vacuum sealers, biosafety cabinets, bioreactors, filtration, and QC (quality control) equipment.
· The ability to execute independently with minimal oversight on technical documentation in accordance with cGxP regulations.
· MUST have experience with test equipment and ability to use test equipment with limited to no supervision (i.e. Kaye Validators, Valprobes, Veriteq Dataloggers, SensiTech Dataloggers, Fluke Multimeters, etc.)
· Must be able to travel and have means of traveling (i.e. a valid driver licenses and transportation).